Crossing the great divide: adoption of new technologies, therapeutics and diagnostics at academic medical centers.

"Technology is dominated by two types of people: those who understand what they do not manage, and those who manage what they do not understand."--Putt's Law

Introduction

At many academic medical centers, adoption of new technologies can be a chaotic and ill-defined process. Traditionally, stakeholder physicians have decided whether to use new medical technologies on the basis of their patients' best interests and wishes. Technologic advances in medicine have the capability to enhance diagnostic and therapeutic options, but in doing so will likely increase the cost of health care. In the era of cost-based charging for medical services, the direct costs of new technologies were not borne by physicians or academic institutions, but simply passed on to payers. Fiscal constraints in health care now increasingly force institutions to assess the absolute and comparative costs of what they do, and to balance these costs against their academic and community missions. If adequate means are not available for evaluating outcomes, diagnostic and therapeutic techniques may be used with little outcome benefit and, in some cases, with high cost and harmful impact.

Today, what is best for an individual patient must be considered relative to what is best for other patients, the institution, and society at large. The competition between physicians' allegiance to their patients and the financial realities confronting society and institutions is increasingly apparent. This tension will likely be amplified by smaller and smaller operating margins in academic medical centers and is already affecting clinical research activities. The unwillingness or inability of premier clinical research facilities to accept technology tested locally may negatively impact the willingness of manufacturers to seek out these institutions as test sites.

A major barrier to a systematic institutional approach to the adoption of innovative technologies and therapeutic methods is what Folland (1997) terms "asymmetry of information." Folland defines "asymmetric information" as "situations in which the parties on the opposite sides of a transaction have different amounts of relevant information." Physicians often lack knowledge and understanding of the financial health of the academic institution and of the impact of new technology. Hospital administrators are usually not well versed in patient management issues or in the technologies themselves. This asymmetry of information leads many academic institutions to make decisions about new technologies in a relative vacuum. Politics, emotion, and the eminence of the physician stakeholder commonly replace an appropriate value-based assessment. Much of the tension around institutional adoption of new technology stems from this asymmetry of information.

Discussions concerning asymmetry of information in healthcare decision-making have traditionally been confined to economists. We believe that this lack of discussion in academic medical centers is counterproductive. Effective technology assessment and adoption requires a balanced and thoughtful review process with information transparency, but such systematic approaches are unfortunately rare.

How then should academic medical institutions contend with new diagnostic or therapeutic technologies? One approach is perhaps best exemplified by a case report concerning new technologies designed to control patient body temperature.

Case Example

Clinicians involved in the care of patients who have suffered a form of acute brain injury called subarachnoid hemorrhage (SAH) have known for some time that fever is a prognostic indicator of a poor outcome. SAH involves the abrupt rupture of blood vessels in the brain, usually from a ruptured aneurysm, and bleeding into the space between the membrane covering the brain and the brain itself. Some 10 to 15% of patients suffering from SAH will die before reaching the hospital. The mortality rate in the first week of hospitalization approaches 40%.

If the patient survives the event, a second critical juncture is reached some days later. Although the cause is unclear, some patients suffer an acute constriction of blood vessels (called vasospasm) in the vicinity of the original bleeding. The vasospasm can cause stroke and additional brain injury or death. Clinicians have seen a link between the development of vasospasm in patients and the presence of a fever. The presence of fever appears to be a predictor of poor outcomes in patients with SAH.

For many years, clinicians have sought to reduce or prevent fever in an effort to reduce the risk of vasospasm. Experimental animal models have demonstrated improved outcomes when cooling methods are employed. Various methods have been studied and are used clinically, Surface cooling methods have included alcohol wipes and cooling blankets. Research continues into the use of more sophisticated devices to achieve surface cooling. Inner core cooling methods have included the insertion of "refrigerating catheters" into large blood vessels. Although several surface and inner core devices have received approval for marketing by the Food and Drug Administration (FDA) on the basis of clinical research, no device has been shown to alter patient outcomes to date. The devices are expected to cost $350-650 more per patient than cooling blankets. Is this a technology that should be adopted by academic medical centers?

The Physician's Role

The physician's role as the patient's primary advocate is defined historically and by professional standards. The American Medical Association (2005) clearly defines this advocacy role in a policy statement. The policy also notes that physicians are not rationers of care, but "... will continue to utilize diagnostic and therapeutic measures and facilities in the best interest of the individual patient." This clearly delineated role would appear, at face value, to be in potential conflict with institutional and administrative desires for cost containment.

It would be somewhat naive to assume that the additional interests of the clinician researcher do not introduce yet another layer of complexity. Academic and financial conflicts are well documented in this regard. In this context, supplier-induced demand for a new technology may drive or be driven by the clinical and research interests of the physician stakeholder. (Taylor, 1995)

An Institutional Response

Academic medical centers have numerous constituencies, all of whom have parochial but reasonable expectations. The tripartite role of academic centers of clinical care, teaching and research are the traditional framework for the institutional expectations. Patients have reasonable expectations for appropriate clinical care while societal expectations also include teaching and research. Physicians reasonably expect to be able to manage patient diagnostic and therapeutic interventions without unnecessary infringements. Beginning in the late 1980's, however, a new stakeholder, third party payers, placed additional and seemingly contradictory demands on academic health centers. Cost containment has been the major concern for the majority of these payers. Academic medical centers now face a multitude of seemingly contradictory goals and objectives, fostered by the expectation that all of these activities will be conducted with appropriate fiscal responsibility in the face of increasingly constrained resources. This new paradigm has the potential for creating discord within the community and threatens the academic and social missions of academic medical centers.

That technology should bring value is not a new concept except perhaps in healthcare. The traditional value equation (Value = Quality/Cost) is transparent in most industries. Healthcare is remarkably different however. Healthcare value, like beauty or pornography, is in the eye of the beholder. Clinicians, patients, insurers and hospital administrators may have remarkably different views of exactly what value a new technology brings to the provision of care.

Recognizing that there is an asymmetric understanding of new technology, that the decision-making process is not transparent at most institutions, and that there is a growing need for a systematic approach to technology assessment and adoption, the Massachusetts General Hospital established the Innovative Diagnostics and Therapeutics Committee (IDT) in 1999. Although the hospital has for nearly thirty years had policies and procedures in place for bringing innovative diagnostic and therapeutic methods to the research domain for appropriate evaluation, no consistent or systematic process existed for informing and overseeing the actual adoption of these methods or new technologies into clinical practice. The creation of the IDT committee was intended to facilitate this process.

The IDT committee is charged with the responsibility of formally evaluating new diagnostic and therapeutic technologies for "quality, safety and efficiency." It is a permanent, standing subcommittee of the Medical Policy Committee and acts in a consultative role to senior management for technology adoption. The committee is also charged with ongoing monitoring of new technology use. Membership is detailed in Table 1. Senior level administrators as well as key stakeholders from the institutional review board (IRB), research administration, biomedical engineering, and medical staff are included. Legal counsel is available and the committee has a medical ethicist member.